None listed
Conditions
Interventions
Procedure/Surgery : The procedure is an image-guided biopsy to collect a sample of tissue from the area of breast cancer. The tumor tissue will be collected either before the patient have breast
Sponsors
NRG Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -The patient must have an ECOG Performance status of 0 or 1 (see Appendix A). -Patients must have had ER analysis performed on the primary breast tumor collected prior to neoadjuvant therapy according to current ASCO/CAP Guideline Recommendations for hormone receptor testing. If negative for ER, assessment of PgR must also be performed according to current ASCO/CAP Guideline Recommendations for hormone receptor testing (http://www.asco.org). -Patients must have had HER2 testing performed on the primary breast tumor collected prior to neoadjuvant chemotherapy according to the current ASCO/CAP Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer (http://www.asco.org). Patients who have a primary tumor that is HER2-positive, HER2-equivocal, or HER2-negative are eligible. -Patients must have a biopsy marker placed within the tumor bed with imaging confirmation (preferably mammogram but ultrasound or MRI is acceptable) of marker placement prior to neoadjuvant chemotherapy. -Patients with operable focal or multifocal (T1-T3, stage II and IIIA invasive ductal carcinoma [all receptor phenotypes]), and who have completed neoadjuvant chemotherapy with a clinical complete response (by clinical examination). -Patients must have achieved a complete or near complete radiologic tumor response on breast imaging with mammogram, ultrasound, and MRI. -Patients must be undergoing breast conserving therapy. -Patient must be able to undergo stereotactic-vacuum-assisted breast biopsy with clip placement after completion of neoadjuvant chemotherapy. -Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen. -Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated. -Patients treated with PD-1 or PD-L1 inhibitors, CDK 4/6 inhibitors, or other immune-based therapy are eligible. -Patients with previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible.
Exclusion criteria
Exclusion criteria: -T4 tumors including inflammatory breast cancer. -Patients with metastatic disease. -Lumpectomy performed prior to study entry. -Patients with any history of prior radiation therapy in the affected breast. -Patients with synchronous ipsilateral invasive breast cancer or any prior history of ipsilateral invasive breast cancer. (Patients with previous ipsilateral/contralateral DCIS or previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible.) -Patients with invasive lobular carcinoma. -Patients who have multicentric disease. -Patients treated with neoadjuvant hormonal therapy only are not eligible. -Patients who are medically unfit to undergo surgical resection. -Patients without breast biopsy marker documented by imaging at tumor bed site prior to initiation of neoadjuvant therapy. -Patients who did not undergo trimodality imaging after completion of neoadjuvant chemotherapy (breast ultrasound, MRI, and mammography). -Patients with one or more of the following imaging criteria from any of the 3 imaging modalities after completion of NCT are not eligible: • Mammogram with malignant appearing calcifications or mass > 1 cm; or • Ultrasound with a hypoechoic area > 2 cm; or • Breast MRI demonstrating a residual mass with rapid rise and washout type III kinetics. -Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results. -Pregnancy or lactation at the time of study registration. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to study registration.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients with post-neoadjuvant chemotherapy negative image-directed biopsy that have a pCR | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of needle cores performed and the proportion of clips retrieved;the distribution of residual cancer burden score;Trimodality imaging algorithm +/- biopsy as a predictor of pCR | — |
Countries
Korea, Republic of
Contacts
Public ContactHaemin Lee
Yonsei University Health System, Severance Hospital
Outcome results
None listed